FDA Drug recall D-0805-2026
Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmo…
- FDA Drug
- Class II
- ongoing
- Published 2026-09-09
On 2026-09-09 the FDA classified a Class II recall of Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmo… by Baxter Healthcare, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0805-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-06 |
| Published | 2026-09-09 |
| Last updated | 2026-09-15 05:30 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3552-48.
Reason
CGMP Deviations
Identifiers
| ndc | 0338-3552-48 |
|---|---|
| ndc | 0338-3551-48 |
| ndc | 0338-3580-48 |
| ndc | 0338-3581-01 |
| ndc | 0338-3582-01 |
| ndc | 0338-3583-01 |
| ndc | 0338-0122-04 |
| ndc | 0338-0124-04 |
| code_info | Lot # NC188678, Exp Date: 12/1/2026; Lot # NC188814, Exp Date: 12/5/2026; Lot # NC188944, Exp Date: 12/8/2026; Lot # NC…Lot # NC188678, Exp Date: 12/1/2026; Lot # NC188814, Exp Date: 12/5/2026; Lot # NC188944, Exp Date: 12/8/2026; Lot # NC193610, Exp Date: 4/21/2027, Lot # NC193665, Exp Date: 4/23/2027. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-15 05:30 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-09-30 · Baxter Healthcare - Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06
FDA Drug · Class I · 2026-09-16 · Baxter Healthcare
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0805-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.